ProMIS Neurosciences Begins Phase 1b Alzheimer's Trial (PRECISE-AD)

ProMIS Neurosciences Inc., a biotechnology firm specializing in precision treatments for neurodegenerative disorders, has announced the launch of its Phase 1b clinical trial named PRECISE-AD. This trial aims to evaluate PMN310, the company's leading therapeutic candidate for treating Alzheimer's disease (AD). PMN310 is a humanized IgG1 antibody that targets amyloid-beta oligomers (AβO), considered crucial contributors to Alzheimer’s progression. By focusing on these toxic oligomers rather than plaque deposits, PMN310 is designed to minimize the risk of amyloid-related imaging abnormalities (ARIA), a common side effect of current therapies, potentially creating a unique therapeutic profile.

The PRECISE-AD trial will examine the safety, tolerability, and pharmacokinetics of PMN310 over a year-long treatment period in 100 patients with mild cognitive impairment (MCI) due to AD or early-stage AD. Additionally, the study will gather data on biomarkers and clinical efficacy indicators to assess PMN310's therapeutic potential. Previous results from a Phase 1a study in healthy individuals indicated a favorable safety and tolerability profile, with findings suggesting potential for effective target engagement in AD patients.

Neil Warma, CEO of ProMIS Neurosciences, highlighted the significance of launching the PRECISE-AD trial as a pivotal step in developing PMN310 for AD. He noted that existing treatments provide limited effectiveness and often come with substantial side effects, such as ARIA, leaving an unmet demand for alternative solutions. Warma emphasized PMN310’s potential to fulfill this need through its selective targeting mechanism.

The PRECISE-AD trial, executed in collaboration with leading U.S. AD treatment centers, is actively enrolling participants. This carefully designed study aims to produce robust clinical data, including biomarker insights and efficacy signals, to guide future development phases. Interim data is anticipated in the first half of 2026, marking an exciting phase for ProMIS Neurosciences and its innovative approach to AD treatment.

Dr. Cameron S. Olezene, Principal Investigator at Flourish Research in Philadelphia, expressed enthusiasm over partnering with ProMIS Neurosciences on PMN310’s development. Monoclonal antibodies that target toxic amyloid-beta species represent the first treatments demonstrating disease-modifying potential for Alzheimer’s. PMN310’s focus on oligomers offers a promising new treatment option for physicians and patients alike.

The PRECISE-AD trial’s name symbolizes ProMIS Neurosciences’ dedication to personalized and effective clinical interventions with precision and excellence in tackling Alzheimer’s Disease. This focus on targeting the root causes of AD underscores the company’s commitment to delivering impactful outcomes for patients.

The Phase 1b trial (NCT06750432) is a randomized, double-blind, placebo-controlled study investigating multiple ascending doses of PMN310 administered intravenously in patients with Stage 3 and Stage 4 AD. The study aims to enroll about 100 participants across 22 U.S. sites. Patients will receive monthly doses at various levels or a placebo over 12 months, with safety, tolerability, and pharmacodynamics evaluations conducted throughout. Regular MRI scans will monitor for ARIA emergence.

PMN310 is a humanized monoclonal antibody engineered to specifically target soluble amyloid-beta oligomers, believed to be the most toxic form of amyloid-beta in Alzheimer’s, leading to neurodegeneration. By focusing on these toxic oligomers, PMN310 aims to address their role as a potential primary cause of AD’s neurodegenerative process.

ProMIS Neurosciences Inc., with offices in Cambridge, Massachusetts, and Toronto, Ontario, is at the forefront of developing antibody therapeutics for neurodegenerative diseases like AD, ALS, and MSA. Their proprietary discovery platform, ProMIS™, identifies novel targets on misfolded proteins, facilitating the development of therapies like PMN310 that specifically target disease-driving oligomers.